NCT03814655

Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software

Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Concordia Dent Srl · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.

Detailed description

Improvements of dental digital technologies are nowadays enabling clinicians to take the digital impressions of the dental arches, therefore avoiding the use of conventional impression materials. Digital impression procedures are claimed to be an approach to improve the accuracy of dental restorations by minimizing the error prone to conventional impression and gypsum model casting, enabling a high degree of standardization. Patients often prefer intraoral scan when compared to the traditional impression. Digital impression is also recommended when patients have remaining teeth that are extremely mobile or misaligned, due to the risk of exfoliation during the conventional impression procedure. Despite its poor scientific and clinical evidence, the use of digital technologies into the daily practice registers a rapidly growing. The precision of digital impressions depends on two different parameters: the resolution of the optical scanning system, and the precision of the matching algorithm which may significantly influence the precision of full arch scans. In order to minimize the effect of matching artifacts, only small parts of the dental arch in close vicinity of the teeth are recommended to be scanned. For prosthetic restoration purpose, several studies regarding the accuracy of digital vs analogue impression have been performed, but none comparing the accuracy of digital vs partially digital workflow for prosthetically driven guided dental implant insertion.

Conditions

• Partially Edentulous Maxilla
• Partially Edentulous Mandible

Interventions

Type	Name	Description
PROCEDURE	Full digital workflow	Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.
PROCEDURE	Partially digital workflow	Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-02-15
• Completion: 2020-07-13
• First posted: 2019-01-24
• Last updated: 2020-07-14

Locations

2 sites across 1 country: Romania